Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Roche Diagnostics Corp.
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C is an FDA 510(k)-cleared medical device (K003120) manufactured by Roche Diagnostics Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 2000. Regulation: 8.